Yale New Haven Hospital
New Haven, Connecticut, 06520, United States
NCT Number: NCT07458087
The main purpose of this study is to evaluate the feasibility and accuracy of the Accuro 3S to provide live guidance when performing a neuraxial technique (e.g., spinal, or epidural).
The Accuro 3S is a new device that was designed to allow for midline live neuraxial guidance. If the device can perform as the manufacturers claim the device will permit the performance of epidurals as close as doing them under fluoroscopy.
Trial opening soon.
Get Notified18 year–85 year
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06520, United States
Feasibility will be assessed in terms of how easily the device can be used and if it poses any discomfort to the patient. Live guidance is defined as the ability to see and change, if needed, the needle trajectory as it is advanced. Accuracy is defined as a measurement of depth by device versus the actual depth of the needle, number of needle attempts (skin punctures) and number of needle redirection.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Provides anatomical guidance during the placement of needles or catheters using real-time visualization.
Time frame: At time of procedure, 1 day
Defined as the number of times the needle is inserted into patients back
Time frame: At time of procedure, 1 day
Defined as number of needle movements in a cephalad, caudal or lateral position.
Time frame: At time of procedure, 1 day
The ultrasound device can be used to measure the distance from skin to epidural space, this will be recorded as the estimated distance to epidural space (EDES). Once the epidural space is accessed the needle will be marked and measured. This will represent the Distance to epidural space (DES). The difference between EDES and DES will provide the accuracy of the device. Mean distance in centimeters (cm).
Time frame: 20 minutes post procedure
Likert scale asking the patient "How satisfied are you with the procedure performed?" Very dissatisfied, dissatisfied, Satisfied, very satisfied, extremely satisfied. Total score range 1-5 with higher scores indicating more satisfaction.
Contact information is provided by the study sponsor or research team.
Yale University
Other
Feasibility and Accuracy of the Accuro 3S
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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